Panel Reviewing Safety Of Banned FDC Drugs To Submit Report In July

Panel Reviewing Safety Of Banned FDC Drugs To Submit Report In July

New Delhi, 24 May 2018: The fate of 349 banned fixed dose combination (FDC) drugs will become clearer in the first week of July, when an expert panel studying the issue presents its report.

The panel conveyed the likely date of submitting its report at a recent meeting with India’s drug advisory authority, minutes of the meeting show.

The committee is reviewing the safety, efficacy and therapeutic justification of these drugs, which were banned in 2015, along with those that were banned before 1988.

At a meeting on 16 May, committee chairman Nilima Kshirsagar informed the Drug Technical Advisory Board (DTAB) that the committee has so far reviewed more than 150 FDCs. Citing that the time given till May is not sufficient to complete the report on all 349 FDCs, Kshirsagar sought time till the first week of July.

“The chairman agreed to the extension of time,” said the minutes of DTAB.

The committee has received representations from the All India Drugs Action Network (AIDAN), Federation of Pharma Entrepreneurs (FOPE), Indian Drugs’ Manufacturers Association (IDMA), Indian Association of Dermatologists Venereologists and Leprologists (IADVL) and Abbott Healthcare Pvt. Ltd.

AIDAN and Abbott Health Care Pvt. Ltd have raised concerns over the appointment of a few members of DTAB’s sub-committee to examine the banned FDCs, citing conflict of interest. Abbott has also asked the-sub committee to consider excluding 15 FDCs approved prior to 1988 and 17 that were approved by the Drug Controller General of India (DCGI).

The DCGI had earlier agreed to allow all pre-1988 FDCs licensed by the state licensing authority, provided proof of pre-1988 license is submitted.

“However, the DTAB members deliberated the issue and were of the view that the sub-committee shall submit the report of all 349 FDCs,” the minutes added.

In December, the Supreme Court had asked DTAB to review whether these drugs should be sold. The FDCs were banned on the recommendation of the Chandrakant Kokate committee, which was set up to study their safety and efficacy.

An FDC drug contains two or more active ingredients in a fixed dosage ratio. In its report submitted on 20 January 2015, the committee led by Kokate, vice-chancellor of KLE University, Karnataka, had deemed these FDCs irrational, and said they posed health risks.

Some of the companies and the pharma groups challenged the government’s notification banning FDCs in court. In December last year, the top court referred the matter to DTAB for a fresh review on whether these drugs should continue to be marketed. The court suggested that DTAB decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and submit its report and recommendations to the government within six months.